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Recruiting NCT07015424

Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

No phase Interventional Weight Regain Weight Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TORe with OverStitch, Intensive lifestyle modification.
Who it may be relevant to
Registry conditions: Weight Regain, Weight Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass

Overview

The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass. Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

Interventions

  • Device TORe with OverStitch
    Transoral Outlet Reduction with OverStitch Endoscopic Suturing System
  • Behavioral Intensive lifestyle modification
    Intensive lifestyle modification program consists of the following: well-balanced calorie-restrictive diet, incorporation of exercise and coaching on lifestyle changes. The program should include personal discussions and goals designed and overseen by the treating physician, obesity management professional or dietician.

Primary outcome measures

  • Total Body Weight Loss [Time frame: 6 Months post enrollment]
Secondary outcome measures (12)
  • Clinically significant weight loss [Time frame: 6, 12 and 24 months post enrollment]
  • Percent TBWL at each visit [Time frame: 6 months post enrollment and through end of study]
  • Change in A1C [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Insulin [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Fasting Glucose [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Cholesterol [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in LDL [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in HDL [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Triglycerides [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Alanine transaminase (ALT) [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Alkaline phosphatase (ALP) [Time frame: 6, 12, 18, and 24 months post enrollment]
  • Change in Aspartate aminotransferase (AST) [Time frame: 6, 12, 18, and 24 months post enrollment]

Eligibility criteria

Inclusion criteria

  • 18 years or older.
  • Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.
  • Willing to have a TORe procedure for the treatment of weight regain.
  • BMI between 30 and 50 kg/m2, inclusive.
  • GJA diameter ≥ 20 mm, confirmed either during a
  • Screening EGD completed ≤ 60 days from study procedure or
  • EGD performed immediately prior to the TORe procedure.
  • Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 6 cm in length).
  • Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study.
  • Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study.
  • Agrees to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study.
  • Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.

Exclusion criteria

  • Current use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins).
  • Current or planned management of Type 2 Diabetes with incretin medications.
  • Inability or unwillingness to comply with assigned treatment or protocol requirements related to visits.
  • Investigator's medical judgement that the subject is not a candidate for the TORe procedure.
  • Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years.
  • Vulnerable subject.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Hoag Memorial Hospital — Irvine
  • Stanford University Medical Center — Stanford
  • Mayo Clinic — Jacksonville
  • Orlando Health Inc — Orlando
  • University of South Florida — Tampa
  • Rush University Medical Center — Chicago
  • Mayo Clinic Foundation — Rochester
  • NYU Grossman School of Medicine — New York
  • … and 1 more center

Identifiers

NCT: NCT07015424 · E7220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗